Adoption of European Commission MDR amendments will help protect patients

March 10, 2023

The Irish Medtech Association, the Ibec group that represents the sector, calls for European regulatory roadmap to maintain patient access to medtech, and restore competitiveness to facilitate the development of more transformative innovation to address unmet clinical needs in the EU.

Ibec Head of Sectors, and Director of Medtech and Engineering Dr Sinead Keogh said: “Medtech, and invitro diagnostics are used for the prevention, diagnosis, monitoring, and treatment of diseases and other conditions. There are more than 500,000 different types of medical technologies on the market. To get into the health system, manufacturers must demonstrate that medical technologies meet EU-wide safety and performance requirements. This week the European Commission’s proposal to amend the transitional provisions for the MDR and IVDR were adopted marking an important step forward. The Irish Medtech Association has been actively advocating to avoid any risks that essential medtech that was previously legally in the health system would be removed. We will continue to support our members to adhere to implementation requirements and new provisions, as well as extended deadlines. 

“Ireland’s global medtech hub is internationally admired for its ability to deliver across the value chain from medtech development to manufacturing and beyond. Our reputation for regulatory excellence, and development of talent help make us a global medtech hub. We’re also delighted to mark the 500th quality and regulatory graduate through our funded programmes at a special event, and as we prepare for the future the Irish Medtech Association, and its members, will continue to collaborate with MedTech Europe and engage with policymakers to tackle outstanding implementation challenges to ensure predictable and efficient access to medtech that improves patients’ lives. Additionally, we will renew efforts to influence a clear regulatory pathway to strengthen Europe’s role as an attractive location to develop and launch medtech that addresses unmet clinical needs with the latest innovations. 

Ibec Medtech and Engineering Head of Funded Projects Dr Ann O’Connell said: “The medtech industry is a proven supporter of the EU MDR goals, and has invested significantly into the transition process, not least by investing in training and developing the talent they need to comply with new regulations. The Irish Medtech Association, in partnership with the Irish Medtech Skillnet, Irish Medtech Springboard and Human Capital Initiative have worked closely with University of Galway, Atlantic Technology University and Shannon Technology University to develop and deliver a range of programmes including the Masters in Regulatory Affairs and Bachelor of Science in Quality Assurance. We’re proud to bring together the current students and alumni of the Master’s in Medical Technology Regulatory Affairs, with our partners from academia and industry to mark the achievements of more than 500 people who have graduated through our programmes over the past number of years. These are the business leaders who will undoubtedly shape and influence the future of medtech development and MDR in Ireland. Congratulations to all, and thank you to our funding partners, including SOLAS, HEA and Skillnet Ireland.”